CClinicalTrials.gg
CompletedNCT02105311Updated Aug 8, 2016

Effect of Selective Laser Trabeculoplasty Versus Travoprost on Circardian Intraocular Pressure

A Phase 4 interventional study of Selective laser trabeculoplasty and Travoprost in Intraocular Pressure, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-08.

Sponsored by Prince of Songkla University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.

Read the detailed description

Selective laser trabeculoplasty is an effective treatment for lowering intraocular pressure in patients with open-angle glaucoma. Clinical evaluations of its effectiveness in individual patients usually are derived from baseline and post-laser measurements of intraocular pressure during office hours in the sitting position. Only a few studies have examined the efficacy of laser trabeculoplasty beyond office hours. Although the 24-hour effect of laser trabeculoplasty has been studied ,the study was conducted before the use of these new and more potent intraocular pressure lowering drugs. So it doesn't have any study to determine the effect of selective laser trabeculoplasty and travoprost to reduce the diurnal and nocturnal variation of Iintraocular pressure.

02

Conditions studied

  • Intraocular Pressure

Keywords

  • Intraocular pressure
  • Selective laser trabeculoplasty
  • Travoprost
  • Ocular surface disease
  • Glaucoma symptom scale
03

In context

Lead sponsor

Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18 year-old
  • Patients who were diagnosed as primary open-angle glaucoma, normal tension glaucoma, and ocular hypertension either newly diagnosed or currently on medical therapy.
  • Agree to participate in the study, accept to be randomized to receive treatment, and willing to sign an informed consent

Exclusion criteria

Exclusion Criteria:

Related to the severity of disease and visual acuity status

  • Advance glaucoma in the study eye
  • Have a very high intraocular pressure that need immediate treatment to prevent retinal vein occlusion (intraocular pressure >30 mmHg)
  • Currently on maximal tolerated medical treatment and unable to control intraocular pressure
  • Currently on oral carbonic anhydrase inhibitor for intraocular pressure control
  • Single eye, the other eye blind from any cause

Related to surgical procedures

  • Prior laser trabeculoplasty
  • Prior glaucoma surgery
  • Prior retinal surgery
  • Underwent less than 3-month cataract extraction
  • Potential need for other ocular surgery within the 2-3-month follow-up period since enrollment Related to underlying and ocular history
  • History of diabetic retinopathy staged as severe non-proliferative or worse
  • Narrow iridocorneal angle
  • Ocular condition precluding visualization of trabecular meshwork
  • Recently have ocular inflammation of any cause
  • Previous history of ocular trauma
  • Pregnant or breast-feeding women Related to the difficulty of having reliable measurements
  • History of refractive surgery or any keratoplastic procedure
  • Corneal opacities or diseases making no suitable tonometry
  • Subjects with having poor or eccentric fixation or nystagmus
  • Excessive eye squeezing
  • Unable to lay down for measuring intraocular pressure in supine position during the night time
  • Unable to have intraocular pressure checked every 2-hour such as have complicated underlying diseases or having sleep deprivation Related to allergy
  • Known allergy to topical anesthesia
  • Known allergy to fluorescein solution
  • Known allergy to travoprost Related to compliance
  • Impairment preventing adequate understanding to sign an informed consent
  • Subject has demonstrated potential for non-compliance with the study protocol
  • Unwilling to be randomized to receive treatment
  • Unwilling to be washed out from currently treated drug(s).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Selective laser trabeculoplasty

    Treating with the selective laser trabeculoplasty

    Device: Selective laser trabeculoplasty

  • Active comparator
    Travoprost

    Using eye drop: travoprost

    Drug: Travoprost

Interventions

  • DeviceSelective laser trabeculoplasty

    Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)

    Also known as: The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)

  • DrugTravoprost

    Travoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA)

    Also known as: Travatan benzalkonium-free

06

What researchers measure

Primary outcomes

  1. Change of circadian intraocular pressure

    intraocular pressure values measured during daytime and nighttime, compare between selective laser trabeculoplasty and travoprost (include pre- and post-treatment intraocular pressure values)

    Time frame: Six weeks after recieving treatment

Secondary outcomes

  1. Position related intraocular pressure

    Intraocular pressure different when measuring in the sitting and supine position (include pre- and post-treatment intraocular pressure values

    Time frame: Six weeks after the treatments

  2. Ocular surface disease

    Using the glaucoma symptom scale-10 (GSS-10) and ocular surface disease questionnaire for evaluation

    Time frame: Six weeks after the treatments

07

Study locations

1 site
  • Songklanagarind Hospital
    Hatyai, Songkhla 90110, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02105311
Lead sponsor
Prince of Songkla University
Responsible party
Weerawat Kiddee (Weerawat Kiddee, Prince of Songkla University) — Principal investigator
First posted
Apr 7, 2014
Start date
Mar 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Aug 8, 2016

Study contacts

Weerawat Kiddee, MD
principal investigator · Prince of Songkla University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion